Health TrialsbyHealthPanel

Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

ConditionMAFLD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDong Hui

About this trial

This trial is expected to enroll 138 MAFLD patients in one clinical center, who will be randomly divided into a placebo group and a Ganzhixiao capsule group in a 1:1 ratio. There will be 69 patients in the Ganzhixiao group and 69 patients in the placebo group. Administer Ganzhixiao capsules or mimetics separately, intervene for 16 weeks, and compare the liver fat content、 ALT、 Changes in indicators such as cytokeratin 18 fragment, FIB-4 score, and LSM score. Among them, MRI-PDFF is the main efficacy evaluation index to evaluate the clinical efficacy of Ganzhixiao capsules in the treatment of MAFLD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 70 years old, with a body mass index (BMI) of at least 24kg/m2;

Diagnosis of NAFLD determined by imaging [ultrasound, computed tomography or magnetic resonance imaging (MRI-PDFF)] or liver biopsy, showing MAFLD or simple steatosis within the last 24 months prior to screening;

MAFLD patients conform to the damp heat syndrome type; ④ Voluntary signing of informed consent form

Disqualifiers

Blood biochemical indicators ALT, AST, BUN are greater than 1.5 times the upper limit of normal values, Cr is greater than the upper limit of normal values, eGFR<60ml/min/1.73m2;

Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;

Type 2 diabetes and pancreatic diseases;

Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • ganzhixiao capsule

    Drug

    Ganzhixiao Capsule is mainly composed of Bupleurum chinense, Herba Artemisiae, Polygonum cuspidatum, Rhubarb and Hawthorn.Take 3 capsules each in the morning, afternoon, and evening, and swallow with warm water after meals for 16 weeks.All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

  • placebo capsule

    Drug

    Take 3 palcebo capsule each in the morning, afternoon, and evening, and swallow with warm water after meals for 16 weeks.All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Clinical study on the treatment of MAFLD with palcebo capsulesPlacebo comparator 1 intervention
Group B: Clinical study on the treatment of MAFLD with Ganzhixiao capsulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MRI-PDFF

MRI PDFF (Magnetic Resonance Proton Density Fat Fraction) is a non-invasive magnetic resonance technique used to evaluate the fat content of the liver. It reflects the concentration of free TG in tissues by measuring the ratio of the proton density of free TG to the total proton density of free TG and water, expressed as a percentage (%).

Time frame
16 weeks

Secondary outcomes

1

ALT

ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage，which is measured in blood .

Time frame
16 weeks
2

CK18

Cell corner fragment 18 (CK18) is mainly used as a specific indicator for evaluating liver cell apoptosis, which can help us understand the degree and nature of liver damage. CK18 is measured in blood.

Time frame
16 weeks
3

FIB-4

The Fibrosis 4 Score (FIB-4) is a non-invasive indicator for assessing the degree of liver fibrosis in patients with chronic liver disease. This scoring system calculates the degree of liver fibrosis using simple blood indicators, including age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count (PLT).

Time frame
16 weeks
4

LSM

The LSM score, also known as Liver Stiffness Measurement, is an indicator used to evaluate the degree of liver fibrosis through FibroScan.

Time frame
16 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dong Hui

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: